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Clinical Trials in Poland / NCT07476196
Recruiting Observational

Poland-Italy Aortic Research Bridge Real World Registry

NCT07476196 · tracked via the Priya Life Science Poland tracker
Sponsor
American Heart of Poland
Phase
Observational
Started
2026-03-01
Last updated
2026-03-20

Condition(s) studied

Abdominal Aortic Aneurysm

Study summary

Objective To pragmatically collect and analyze patient-level clinical, procedural, and outcome data from participating centers in Italy and Poland on the use of the PERCUTEK Tycheseal™ stent-graft system for the endovascular repair of abdominal aortic aneurysms. The study aims to generate high-quality, real-world evidence on the technical success, safety, and mid-term outcomes of the device.

Study Design This is a pragmatic, observational, multicenter physician-initiated registry that will collect patient-level data for all eligible patients undergoing PERCUTEK Tycheseal™ device implantation. Each site will enter data into a standardized paper case report form (CRF), including demographic, anatomical, procedural, and follow-up variables. Sites will be expected to comply with data entry timelines and quality control checks. The total projected enrollment is 120-200 patients across all sites over an expected 18 month inclusion period.

The target enrollment is 120-200 patients across all participating sites.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Anatomical Inclusion Criteria (as per IFU): * Morphologically suitable aneurysm * Neck length ≥ 10 mm * Neck diameter suitable for 20-36 mm body (considering 10-20% of oversizing) * Neck angle: infrarenal ≤ 75° * Distal seal zone ≥ 10 mm * Iliac arteries 8-20 mm diameter Patient Inclusion Criteria: * Age \>18 years * Signed informed consent * Pregnancy test for premenopausal women Exclusion Criteria: * Anatomical unsuitability * Subject has a life expectancy \< 1 year * Circumferential thrombus in neck * Ruptured aneurysm * Renal arteries from aneurysm sac * Dominant IMA with obstructed visceral vessels * Internal iliac artery aneurysms (unless pre-treated) * Subject has a known contraindication dual antiplatelets therapy or contrast media, * Selected patients with chronic kidney failure (CKF) can undergo EVAR using standard contrast or CO2 as contrast agent. * Previous aortoiliac surgery or EVAR * Recent stroke/MI (\< 3 months) * Allergy to device materials

Primary outcome measure(s)

  • Technical success of the PERCUTEK Tycheseal™ stent-graft implantation, defined as successful deployment at the intended site with the absence of immediate type I or III endoleaks and no requirement for unplanned conversion to open repair. — 12 months
  • Freedom from aneurysm sac enlargement, defined as no increase ≥5 mm in the maximum transverse aortic aneurysm diameter at 12 months compared to baseline imaging. — 12 month
  • Freedom from type I or III endoleaks, confirmed by Doppler ultrasound or angio CT at the 6- and 12-month follow-ups. — 6 and 12 months
  • Freedom from aneurysm rupture during the 12-month follow-up period. — 12 months
  • Freedom from stent-graft migration resulting in a serious adverse event or requiring secondary intervention. — 12 months
  • Freedom from any stent-graft occlusion at 12 months. — 12 months

Trial sites (26)

FacilityCityRegionStatus
Clinica Pineta Grande Castel Volturno Italy Not Yet Recruiting
Centro Cuore Morgagni Catania Italy Not Yet Recruiting
IRCCS Neuromed - Istituto Neurologico Mediterraneo Pozzilli Italy Not Yet Recruiting
Arcispedale Santa Maria Nuova Reggio Emilia Italy Not Yet Recruiting
Policlinico San Donato San Donato Milanese Italy Not Yet Recruiting
Uniwersytecki Szpital Kliniczny w Białymstoku Bialystok Poland Recruiting
Szpital Wojewódzki w Bielsku-Białej Bielsko-Biala Poland Recruiting
Wojewódzki Szpital Specjalistyczny nr 4 Bytom Poland Recruiting
Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów Chrzanów Poland Recruiting
118 Szpital Wojskowy z Przychodnią SPZOZ Ełk Poland Recruiting
Szpital im. Św. Wincentego a Paulo Gdynia Poland Recruiting
Wojewódzki Szpital Zespolony Kielce Poland Recruiting
Bonifraterskie Centrum Medyczne Krakow Poland Recruiting
Krakowski Szpital Specjalistyczny im. JPII Krakow Poland Recruiting
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Lublin Poland Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 Lublin Poland Recruiting
Wojewódzki Szpital Specjalistyczny w Lublinie Lublin Poland Recruiting
Uniwersytecki Szpital Kliniczny w Opolu Opole Poland Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu Poznan Poland Recruiting
Wojewódzki Szpital im. Św. Ojca Pio Przemyśl Poland Recruiting
Uniwersytecki Szpital Kliniczny Nr 2 PUM Szczecin Poland Recruiting
Mazowiecki Szpital Bródnowski Warsaw Poland Recruiting
Narodowy Instytut Kardiologii Warsaw Poland Recruiting
Uniwersyteckie Centrum Kliniczne WUM Warsaw Poland Recruiting
Wodzisławskie Centrum Medyczne Wodzisław Śląski Poland Recruiting
Szpital Uniwersytecki im. Karola Marcinkowskiego Zielona Góra Poland Recruiting

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Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease Recruiting

Other trials for the same condition

Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07476196 on ClinicalTrials.gov ↗ ← All trials in Poland